Package for medical product

ABSTRACT

A package for a multi-component medical device is disclosed. The package includes a bottom portion with cavities providing individual access to different components of the medical device, thereby enabling a user to remove components from the package in any order without disturbing the remaining component or components. The package also includes a barrier affixed to the bottom portion for sealing the package.

RELATED APPLICATIONS

This application is division of U.S. patent application Ser. No.13/830,009, filed on Mar. 14, 2013, which is hereby incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to packaging, and more particularly, to apackage for a medical product.

2. Description of the Related Art

Packaging for medical devices, particularly multi-component medicaldevices, such as insulin infusion devices, can include a breathable,sealable bag or pouch, or multiple packages for the complete set ofcomponents. Packaging can also include a base portion for housing thecomponents along with a barrier that seals the housing portion. Althoughthe process can be expensive, such housings are often injection moldedto provide a desired shape for housing the components.

One problem with such bags or other packaging, however, is that thecomponents are often placed together in a single compartment. Componentscan also shift location within the packaging during shipping. To accessone of the components, the patient and/or other end user often mustremove more than one, and sometimes all, of the components from thepackaging. Additionally, the patient and/or other end user may beconstrained to remove items in a particular order, even if that is notthe order desired by the user. Although a user other than a patient (forexample, a health care professional) can use a packaged medical product,for brevity the term “user” will be employed hereinafter to refer to apatient and/or other end user.

Moreover, with packages having removable sealing barriers, it is oftendifficult to open such packages, particularly if the user's dexterity islimited. Accordingly, to provide easy user access to a medical device,as well as protecting the device during shipping, improvements in thepackaging of medical products is needed.

SUMMARY OF EMBODIMENTS OF THE INVENTION

Accordingly, it is an aspect of the present invention to provideimproved packaging for medical products.

The foregoing and/or other aspects of the present invention are achievedby providing a package for a multi-component medical device, including abottom portion with cavities providing individual access to differentcomponents of the medical device, thereby enabling a user to removecomponents from the package in any order without disturbing theremaining component or components. The package also includes a barrieraffixed to the bottom portion for sealing the package.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a method of packaging a multi-component medicaldevice. The method includes forming a bottom portion with cavities thatprovide individual access to different components of the medical device,thereby enabling a user to remove components from the package in anyorder without disturbing the remaining component or components. Themethod also includes affixing a barrier to a rim of the bottom portionto seal the package.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a package for a medical device. The packageincludes a bottom portion that includes at least one cavity for housingthe medical device, and a flange providing a sealing surface. Thepackage also includes a barrier affixed to the flange for sealing thepackage. The flange includes an informational marking that is raisedrelative to the remainder of the flange to provide a lifting tab of thebarrier when the barrier is affixed to the flange of the bottom portion.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a package for a multi-component medical device.The package includes a bottom portion having at least one cavity forhousing the medical device, a platform insertable into the cavity, forraising at least one of the components of the medical device above afloor of the cavity, and a barrier affixed to the bottom portion forsealing the package.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a package for a medical device. The packageincludes a bottom portion that includes at least one cavity for housingthe medical device, and a flange providing a sealing surface. Thepackage also includes a barrier affixed to the flange for sealing thepackage. The flange includes an informational marking that is recessedrelative to the flange to provide a lifting tab for the barrier when thebarrier is affixed to the flange of the bottom portion.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a package for a medical device. The packageincludes a bottom portion that includes at least one cavity for housingthe medical device, and a flange providing a sealing surface. Thepackage also includes a barrier affixed to the flange for sealing thepackage. The flange includes a recessed portion to provide a lifting tabfor the barrier when the barrier is affixed to the flange of the bottomportion, and the recessed portion includes a marking that is recessedfrom the recessed portion.

Additional and/or other aspects and advantages of the present inventionwill be set forth in the description that follows, or will be apparentfrom the description, or may be learned by practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and/or other aspects and advantages of embodiments of theinvention will be more readily appreciated from the following detaileddescription, taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a top view of a bottom portion of a package in accordance withan embodiment of the present invention;

FIG. 2 is a front view of the bottom portion of FIG. 1;

FIG. 3 is a left side view of the bottom portion of FIG. 1;

FIG. 4 is a right side view of the bottom portion of FIG. 1;

FIG. 5A is a side view of a package including the bottom portion of FIG.1 with a medical device disposed therein in accordance with anembodiment of the present invention;

FIG. 5B is a partial side view of a package including an alternativeembodiment of a bottom portion in accordance with an embodiment of thepresent invention;

FIG. 6 is an exploded perspective view of a bottom portion and aplatform of a package in accordance with another embodiment of thepresent invention;

FIG. 7 is a perspective view of the elements of FIG. 6 in an assembledstate;

FIG. 8 is a top view of the assembled elements of FIG. 6;

FIG. 9 is a rear view of the assembled elements of FIG. 6;

FIG. 10 is a right side view of the assembled elements of FIG. 6;

FIG. 11 is a cross-sectional view of a package including the assembledelements of FIG. 6 with a medical device disposed therein in accordancewith an embodiment of the present invention;

FIG. 12 is a side view of the package and medical device of FIG. 11;

FIG. 13 is a perspective view of a bottom portion of a package inaccordance with another embodiment of the present invention;

FIG. 14 is a top view of the bottom portion of FIG. 13;

FIG. 15 is a right side view of the bottom portion of FIG. 13;

FIG. 16 is a perspective view of the bottom portion of FIG. 13 with amedical device disposed therein in accordance with an embodiment of thepresent invention;

FIG. 17 is a cross-sectional view of a package including the bottomportion of FIG. 13 with a medical device disposed therein in accordancewith an embodiment of the present invention;

FIG. 18 is a perspective view of a bottom portion of a package inaccordance with another embodiment of the present invention;

FIG. 19 is another perspective view of the bottom portion of FIG. 18;

FIG. 20 is a right side view of the bottom portion of FIG. 18;

FIG. 21 is a perspective view of a package in accordance with anembodiment of the present invention, including the bottom portion ofFIG. 18;

FIG. 22 is a cross-sectional view of the bottom portion of FIG. 18;

FIG. 23 is a cross-sectional view of a bottom portion in accordance withanother embodiment of the present invention;

FIG. 24 is a cross-sectional view of a package including the bottomportion of FIG. 23 with a medical device disposed therein in accordancewith an embodiment of the present invention;

FIG. 25 is a perspective view of a nested pair of bottom portions ofFIG. 13 in accordance with an embodiment of the present invention;

FIG. 26 is a left side view of the nested pair of bottom portions ofFIG. 25;

FIG. 27 is a right side view of the nested pair of bottom portions ofFIG. 25;

FIG. 28 is a perspective top view of the nested pair of bottom portionsof FIG. 25;

FIG. 29 illustrates a plurality of nested pairs of packages in a shelfcarton in accordance with an embodiment of the present invention;

FIG. 30 illustrates a plurality of shelf cartons in a shipping carton inaccordance with an embodiment of the present invention; and

FIG. 31 illustrates a plurality of shipping cartons on a pallet inaccordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

Reference will now be made in detail to embodiments of the presentinvention, which are illustrated in the accompanying drawings, whereinlike reference numerals refer to like elements throughout. Theembodiments described herein exemplify, but do not limit, the presentinvention by referring to the drawings. As will be understood by oneskilled in the art, terms such as up, down, bottom, top, above, andbelow are relative, and are employed to aid illustration, but are notlimiting.

FIG. 1 is a top view of a bottom portion 100 of a package 102 inaccordance with an embodiment of the present invention. FIG. 2 is afront view of the bottom portion 100, and FIGS. 3 and 4 are respectiveleft and right views of the bottom portion 100. The bottom portion 100is transparent and includes a cavity 104 for holding or housing amedical product, for example, a multi-component medical device. Assubsequently described in greater detail, the cavity 104 includes a mainportion 106 with a floor 108, and a platform or shelf 110 that is raisedabove the floor 108.

The bottom portion 100 also includes a flange 112 that provides asealing surface for a barrier 114 (see, for example, FIG. 5A). Thebarrier 114 is preferably gas-permeable, so that subsequent to sealing,the contents of the package 102 can be sterilized with gas. For example,the barrier 114 can be Tyvek® material. Preferably, however, the barrier114 is paper coated with an adhesive polymer on one side for securingthe barrier 114 to the bottom portion 100. A heat press can be used tosecure the barrier 114 to the bottom portion 114. One skilled in the artwill appreciate that other methods of securing the barrier 114 to theflange 112 can be implemented without departing from the scope of thepresent invention. As an alternative to gas sterilization, the package102 and its contents can be irradiated.

Preferably, the bottom portion 100 is theremoformed using transparentpolyethylene terephthalate (PET) film. More preferably, the PET is anamorphous PET (APET). Most preferably, the bottom portion is made ofPentamed® TerraPET® film, which is available from Klockner Pentaplast.TerraPET® film is a sterilizable rigid APET film that is made with up to30% renewable resource content. More specifically, TerraPET® film ismade from two raw materials, one of which is derived from ethanol ratherthan petroleum. Heretofore, TerraPET® has not been used in medicaldevice packaging on the market.

One advantage of using PET is to allow the embossing of informationalmarkings, symbols, or characters during the thermoforming process. Forexample, as shown in FIG. 3, a recycling indicator 116 can be formed ina side wall of the bottom portion 102. In addition, one or morealphanumeric characters or logos 118 can be formed, for example, byembossing, in the flange 112. Such informational markings 118 can serveseveral purposes. A character or logo 118 can illustrate a trademark oradvertising, for example, to represent the source of the product housedin the bottom portion 102. Alternatively, the informational marking 118can provide instructions, such as a direction for removing the barrier114.

As another example, according to an embodiment best shown in FIG. 5A,the informational marking 118 can be raised relative to the flange 112to provide a location of a lifting tab 120 of the barrier 114 when thebarrier 114 is connected to the bottom portion 100. Preferably, adhesiveis not applied to the raised informational marking 118 when the barrier114 is secured to the bottom portion 100, thereby providing the liftingtab 120. Even if adhesive is applied to the informational marking 118,however, because the informational marking 118 is raised relative to theflange 112, this provides an area (surrounding the informational marking118) in which the barrier is not secured to the flange 112. Thus, theuser is more easily able to lift the lifting tab 120.

As an alternative, however, the informational marking 118 can also berecessed relative to the flange 112, as shown in FIG. 5B. As notedpreviously, it is preferable that the barrier 114 is paper with anadhesive polymer on one side thereof. More preferably, the adhesivepolymer is a heat-activated adhesive polymer, so that the barrier 114can be secured to the bottom portion 100, for example, on the flange112, using a heat press. Having the informational marking 118 recessedbelow the flange 112 allows the heat press to have a flat surface.Preferably, however, the informational marking 118 still provides alifting tab 120 for the barrier; the adhesive does not adhere to theinformational marking 118 because it is recessed.

Referring back to FIG. 5A, the package 102, which includes the bottomportion 100 and the barrier 114, can house a multi-component medicaldevice 122, such as an infusion set 122. The device 122 includes a lineset or tubing set 124 and an insertion set or introducer assembly 126.The line set 124 includes a pump connector 128 for connecting to a pump,a fluid connector for connecting to a base, and tubing 132 connectingthe pump connector 128 to the fluid connector 130.

The insertion set includes a base 134 with an adhesive pad 136 securedto its distal side for securing the device 122 to a patient's skin. Theadhesive pad 136 has a removable liner 138 to protect the patient-sideadhesive. An insertable cannula 140 (see, for example, FIG. 11) dependsfrom the distal side of the base 134. According to one embodiment, thecannula 140 is a flexible cannula and the device 122 includes anintroducer needle 142 (see, for example, FIG. 11) with a user interfaceor handle 144 for removing the introducer needle 142 from the base 134.One skilled in the art will appreciate, however, that other types ofcannulas, such as rigid steel needles that do not require a separateintroducer, can be used without departing from the scope of the presentinvention.

The medical device 122 also includes a removable needle guard 146 toprotect the cannula and the introducer needle prior to use, and toshield the introducer needle subsequent to removal of the introducerneedle from the base 134. The length of the cannula 140 can varydepending on desired insertion depth and desired depth for delivery of amedicament. For example, the cannula 140 can be 6 mm or 9 mm. The lengthof the needle guard 146 can vary accordingly. The device 122 can alsoinclude a sterile cover 148 (see, for example, FIG. 16) for covering aport of the base when the fluid connector 130 is not connected to theport, for example, when bathing or swimming.

The cavity 104 of the bottom portion 100 provides a space to house theline set 124, with the tubing 132 resting on the floor 108, and theplatform 110 houses the insertion set 126, providing clearance for theneedle guard 146 below the level of the platform 110.

FIG. 6 is an exploded perspective view of a bottom portion 150 and aplatform 152 of a package 154 in accordance with another embodiment ofthe present invention, and FIG. 7 is a perspective view of the bottomportion 150 and the platform 152 in an assembled state. FIGS. 8-10 arerespective top, rear, and right side views of the assembled bottomportion 150 and platform 152.

Like the previously-described bottom portion 100, the bottom portion 150is transparent and includes a cavity 156 for holding or housing amedical product, for example, a multi-component medical device. Thecavity 156 includes a main portion 158 with a floor 160 and a platformportion 162 for receiving the platform 152, which is also preferablytransparent. The bottom portion also includes a flange 164 for receivingthe barrier 114.

The platform 152 has a platform flange 166. According to one embodiment,the platform 152 has an opening 168 on the top thereof and is hollow.Preferably, the bottom of the platform is also open. The platformportion 162 of the platform portion 162 has a shape that corresponds tothe platform flange 166, and thus, once the platform 152 is insertedinto the platform portion 162, the platform portion retains the platformflange 166 and substantially prevents lateral movement of the platform152 relative to the bottom portion 150. The corresponding shapes can bemultifaceted, for example, triangular, rectangular, or the like, or thecorresponding shapes can be rounded, for example, elliptical, ovoid,circular, conical, or, as shown in FIGS. 6-12, frusto-conical.

According to one embodiment, the platform portion 162 of the bottomportion 150 also has a retaining rim disposed near the floor 160 tovertically retain the platform flange 166. As the platform 152 isinserted into the platform portion and the platform flange 166 engagesthe retaining rim, at least one of the flange 166 and the rim deforms ordeflects to permit relative displacement. According to one embodiment,the retaining rim and the platform flange 166 provide a snap-fitengagement to retain the platform 152 in the bottom portion subsequentto its installation therein. According to one embodiment, the retainingrim is discontinuous, thereby providing a plurality of retaining rimsarrayed around the perimeter (for example, the circumference) of theplatform portion 162. According to one embodiment, however, there is noretaining rim, and although the platform portion 162 prevents lateralmovement of the platform 152 relative to the bottom portion 150, theplatform 152 is not prevented from displacing vertically.

As best shown in FIGS. 11 and 12, which illustrate the barrier 114connected with the bottom portion 150, when housing the infusion set122, the tubing 132 coils around the platform 152, and the insertion set126 rests on top of the platform 152, with the needle guard 146extending through the opening 168 in the top of the platform 152.

FIG. 13 is a perspective view of a bottom portion 200 of a package 202in accordance with another embodiment of the present invention. FIGS. 14and 15 are respective top and right side views of the bottom portion200. FIG. 16 is a perspective view of the bottom portion with themedical device 122 disposed therein, and FIG. 17 is a cross-sectionalview of the package 202 (including the bottom portion 200 and thebarrier 114) with the medical device 122 disposed therein.

The bottom portion 200 is transparent and has a plurality of cavitiesthat are organized into regions for each component of themulti-component medical device 122. In other words, the bottom portion200 includes a designated region for each component. This arrangementprovides individual access to different components of the medical device122, thereby enabling the user to remove components from the package 202in any order without disturbing the remaining component(s).

For example, the bottom portion 200 includes a region 204 for theinsertion set or introducer assembly 126, a region 206 for the line setor infusion tubing set 124, and a region 208 for the sterile cover 148.Each of these regions 204, 206, and 208 are recessed from an uppersurface 210 of the bottom portion 200. In this embodiment, the uppersurface 210 is a flange 210.

Preferably, the infusion tubing set region 206 includes a first ortubing region 212 designated to house the tubing 132, and a second orconnector region 214 designated to house the pump connector 128 and thefluid connector 130. As shown most clearly in FIG. 15, the connectorregion 214 is recessed further from the flange 210 than the tubingregion 212.

In addition, the introducer assembly region 204 preferably includes apair of substantially concentric recesses: a handle recess 216 with abottom forming a platform for receiving the adhesive liner 138, and aguard recess 218 for receiving the needle guard 146. The majority of thehandle recess 216 is enclosed, thereby preventing lateral movement ofthe introducer assembly of insertion set 126 when it is disposed withinthe introducer assembly region 204. As best shown in FIG. 15, the guardrecess 218 is recessed farther from the flange 210 than the handlerecess 216.

As shown in FIGS. 13-17, the introducer assembly region 204 iscontiguous with both the sterile cap region 208 and the connector region214, which is a part of the tubing set region 206. In this embodiment,however, the sterile cap region 210 is not contiguous with the connectorregion 214 or the tubing region 212. This arrangement allows the user toremove components from the package 202 in any order without disturbingthe remaining component(s). One skilled in the art will appreciate thatthe contiguity and recess depth of the various regions can be alteredwithout departing from the scope of the present invention.

FIGS. 18 and 19 are perspective views of a bottom portion 250 of apackage 252 in accordance with another embodiment of the presentinvention. The bottom portion 250 is transparent and is substantiallysimilar to the bottom portion 200, except that a portion 254 of theflange 256 is recessed below the flange 256. This recessed portion 254provides a location for the lifting tab 120 of the barrier 114. In otherwords, the barrier 114 is preferably not adhered to the recessed portion254. Put another way, the flange 256 provides a surface for adhering thebarrier 114, thereby sealing the contents of the package 252. Butbecause the portion 254 is recessed, when the preferably flat heat pressactivates the adhesive of the barrier 114 and seals the barrier 114 ontothe flange 256, the barrier is preferably not pressed against therecessed portion 254. Thus, the portion of the barrier 114 above therecessed portion 254 becomes the lifting tab 120.

According to one embodiment, the recessed portion 254 has a marking 258.Preferably, the marking 258 is recessed below the recessed portion 254,as best shown in FIG. 20. In such an embodiment, even if the heat pressadheres the barrier 114 to the recessed portion 254, because the markingis recessed below the recessed portion 254, the barrier will preferablynot adhere to the marking 258, thereby allowing the user to peel backthe lifting tab more easily at the location of the marking 258.Preferably, the marking 258 is an informational marking 258.

FIG. 21 is a perspective view of the package 252 illustrating thebarrier adhered to the bottom portion 250 and sealing the package 252.

FIG. 22 is a cross-sectional view of the bottom portion 250. A floor 260of a guard recess portion 262 that receives the needle guard 146 issubstantially flat. In contrast, as shown in FIG. 23, the bottom portion270 has a guard recess portion 272 with a floor 274 having a mound orhump 276 protruding toward the flange 278 (and the barrier 114, as shownin FIG. 24). The mound or hump 276 engages a bottom of the needle guard146 to help prevent displacement of the insertion set 126 relative tothe bottom portion 270, as shown FIG. 24.

FIG. 25 is a perspective view of a nested pair of bottom portions 200(of FIG. 13) in accordance with an embodiment of the present invention.FIGS. 26 and 27 are respective left and right side views of the nestedpair of bottom portions 200, and FIG. 28 is a perspective top view ofthe nested pair of bottom portions 200.

Although the barriers 114 are removed for clarity, FIGS. 25-28illustrate that a pair of bottom portions 200 (and thus, packages 202)are contiguously nestable to minimize a packing volume thereof. In otherwords, when one package 202 is inverted relative to another package 202and longitudinal axes (i.e., along the tubing set regions 206) arealigned, the packages 202 can fit or nest together to form a nested pairof packages. Put another way, nesting packages 202 inter-fit to savespace, with or without interlocking. Interlocking can be defined as aresistance to separation in one or more directions, and can be achievedby friction and/or mechanical engagement.

For example, as shown in FIG. 29, a barrier 114 of one of the packagesof a nested pair can be positioned adjacent to a barrier 114 of one ofthe packages of another nested pair. When this is accomplished aplurality of nested pairs are placed in a shelf carton 220 with thelongitudinal axes of the packages 202 being oriented substantiallyperpendicular to an opening of the shelf carton 220, the nested pairsform a top row and a bottom row. In FIG. 29, the top row is the row withthe introducer assembly region 204 on top. In other words, the back row.Because the nested pairs of packages 202 preferably do not interlock,each of the packages 202 in the top row is freely removable from theshelf carton 220 through the opening.

According to one embodiment, the multi-component infusion set 122 can beused for about three days before being replaced. Thus, a user typicallywould use ten infusion sets 122 per month. Accordingly, a shelf carton220 that contains ten infusion sets 122 would generally be a one-monthsupply. The shelf carton 220 shown in FIG. 29 is sized to contain teninfusion sets 122.

As shown in FIGS. 30 and 31, a shipping carton 222 can be sized to fitfifteen shelf cartons 220, and a standard pallet 224 can hold fortyshipping cartons 222. Thus, a standard pallet 224 can hold 6,000infusion sets 122 (10 infusion sets per shelf carton×15 shelf cartonsper shipping carton×40 shipping cartons per pallet). As previouslynoted, the length of the cannula 140 and the needle guard 146 can varyaccording to desired cannula insertion depth. The guard recess portion218 of the package 202 (for example, FIGS. 13-17) can be used for longercannula and needle guard combinations, and therefore has a greater depth(distance from its floor to the flange 210) than the guard recessportion 262 of the package 250 (for example, FIGS. 18-24), which can beused for shorter cannula and needle guard combinations. FIGS. 25-31 andthe calculation regarding infusion sets per pallet illustrate thepackage 202. If the package 250 with the shorter guard recess portionwas employed, a standard pallet could hold approximately 7200 packages.

As previously disclosed, one or more raised or recessed formations,preferably in the form of informational markings, are provided on theflange to allow for easier barrier 114 removal by a user. Additionally,the platform 152 can be inserted into the bottom portion 150 to form atwo-piece bottom housing for a medical device. Further, the bottomportion 200 allows the individual parts of the medical device 122 to beremoved independently of one another. Each of the previously-describedbottom portions 100, 150, and 200 can be formed using thermoforming.Moreover, by employing packages 202 as shown, the packages 202 can benested, and thus, take up less space in and/or reduce the size of ashelf carton.

Although only a few embodiments of the present invention have been shownand described, the present invention is not limited to the describedembodiments. Instead, it will be appreciated by those skilled in the artthat changes may be made to these embodiments without departing from theprinciples and spirit of the invention, the scope of which is defined bythe appended claims and their equivalents.

What is claimed is:
 1. A combination, comprising: a multi-componentmedical device; and a package for the multi-component medical device,the package comprising: a bottom portion having at least one cavity forhousing the medical device, the cavity having a floor at a bottomthereof; and a platform insertable into the cavity and onto the floor,at least a portion of a periphery of the platform contacting the floor,the platform being hollow and having openings on a top and bottomthereof, the top opening being disposed on the top of the platform andconfigured to receive a portion of at least one of the components of themedical device therethrough; wherein a first portion of the medicaldevice is disposed on the top of the platform, and a second portion ofthe medical device extends from the first portion through the topopening; and wherein the platform is configured to maintain the secondportion of the medical device above the floor and prevent contacttherewith.
 2. The combination according to claim 1, further comprising abarrier affixed to the bottom portion for sealing the package.
 3. Thecombination according to claim 1, wherein the bottom portion includes aplatform portion having a shape corresponding to a shape of theplatform, the platform portion being configured to substantially preventlateral movement of the platform once the platform is inserted into theplatform portion.
 4. The combination according to claim 1, wherein themulti-component medical device comprises an infusion set.
 5. Thecombination according to claim 1, wherein the multi-component medicaldevice further comprises tubing; and the platform is configured for thetubing to be wound around the platform.
 6. The combination according toclaim 1, wherein the platform is frusto-conical.
 7. The combinationaccording to claim 1, wherein the top of the platform is spaced from thebottom opening to prevent the second portion of the medical device fromcontacting the floor.